Risperidone
- Product NDC
- 0378-3512
- 11-digit product format
- 003783512
- Labeler code
- 0378
- Product ID
- 0378-3512_bd55c402-c772-4adf-a9cc-129ab7f67fee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076288
- Marketing category
- ANDA
- Marketing start
- 2008-09-17
- Marketing end
- 2020-09-30
- Substance
- RISPERIDONE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | RISPERIDONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| RISPERIDONE | ACTIVE INGREDIENT | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| RISPERIDONE | ACTIVE MOIETY | L6UH7ZF8HC | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | RISPERIDONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed RxNorm Mappings#